Amgen’s Kyprolis Meets Goals in Phase III Multiple Myeloma Study
By Alex Keown
A late-stage study shows that a stronger weekly dose of Amgen’s Kyprolis combined with dexamethasone had a greater progression-free survival benefit than a twice-weekly dose of the drug at the approved dosing level.
On Monday, Amgen revealed top-line results from its Phase III A.R.R.O.W. trial that showed relapsed and refractory multiple myeloma patients taking a stronger once-weekly dose lived 3.6 months longer without a worsening of the disease than those patients on the twice per week dose. The median progression-free survival in the once-per-week group was 11.2 months, compared to the 7.6 months for patients taking the twice-per-week dose combined with dexamethasone. Patients on the once-weekly arm received a 70 mg dose, while the twice-per-week arm received a 27 mg dose each time.
“Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma,” said Sean Harper, executive vice president of Research and Development at Amgen. “We are encouraged by the efficacy and safety profile of Kyprolis and dexamethasone administered once-weekly in the A.R.R.O.W. study.”
The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia, Amgen said.
In the A.R.R.O.W. study, Kyprolis plus dexamethasone was administered to patients who received at least two but no more than three prior therapies, including bortezomib and an IMiD (immunomodulatory imide drug). The primary endpoint of the trial was PFS, defined as the time from randomization to disease progression or death. Secondary endpoints included overall response rate, overall survival, and safety and tolerability.
While the results appear promising, shares of Amgen declined Monday, closing at $180.53. This morning shares are down slightly, trading at $180.26 as of 11:24 a.m.
Amgen did not provide additional information as to when it might seek regulatory approval for expanded use of Kyprolis. In July 2015, the FDA approved Kyprolis as part of a combination treatment with Revlimid and dexamethasone for multiple myeloma patients who have received one to three prior lines of therapy. Kyprolis has also been approved as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. Kyprolis came to Amgen in 2013 as part of that company’s $10 billion acquisition of Onyx Pharmaceuticals.
There are more than 118,000 people living with, or in remission from, multiple myeloma in the United States. Approximately 30,280 Americans are diagnosed with multiple myeloma each year and 12,590 patient deaths are reported on an annual basis, Amgen said.